Acute pancreatitis is the most common serious complication of ERCP which occasionally could be fatal. Multiple drugs have been examined for prevention of this side effect with generally uncertain results. This study is an effort for prevention of this complication with using oral N acetyl Cysteine.
Materials and Methods:
Overall 100 patients who were candidate for ERCP divided randomly to two groups. In the group N, 1200 mg N Acetyl Cysteine with 150cc water prescribed orally 2 hours before ERCP and in group P, 150cc water prescribed as placebo. Serum Amylase and Lipase have measured before and 24 hours after ERCP and prevalence of pancreatitis and duration of admission in each group were determined and compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008094545N1
Registration date:2012-12-23, 1391/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Pezhman Alavi nejad
Name of organization / entity
Ahvaz Jondishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1391 2533
Email address
ehajiani@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz jondi shapur medical university
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EVALUATION OF N ACETYL CYCTEIN IN PREVENTION OF POST ERCP PANCRETITIS: A DOUBLE BLIND randomized PILOT STUDY
Public title
Evaluation of NAC for prevention of post ERCP pancreatitis: a prospective double blind randomized pilot study
Purpose
Prevention
Inclusion/Exclusion criteria
every patient candidate for ERCP in GI ward of Ahwaz Imam hospital except those with preexisting pancreatitis or uncontroled diabetes melitus
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research center of ahwaz jondi shapur univercity
Street address
department of reaserch and technology, medical univercity, shahid chamran univercity
City
ahwaz
Postal code
Approval date
2011-05-21, 1390/02/31
Ethics committee reference number
ETH-272
Health conditions studied
1
Description of health condition studied
post ERCP pancreatitis
ICD-10 code
K85.8
ICD-10 code description
other acute pancreatitis
Primary outcomes
1
Description
serum lipase
Timepoint
before and after ERCP
Method of measurement
level of enzyme in serum
2
Description
serum amylase
Timepoint
before and 24 hours after ERCP
Method of measurement
measurement of enzyme level in serum
Secondary outcomes
1
Description
incidence of pancreatitis
Timepoint
24 hours after ERCP
Method of measurement
enzyme level in serum
2
Description
abdominal pain
Timepoint
after ERCP
Method of measurement
to be or not to be
3
Description
duration of addmision
Timepoint
how long
Method of measurement
how many days
Intervention groups
1
Description
NAC 1200mg in 150 cc water
Category
Prevention
2
Description
150cc water
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
GI department of Ahwaz Imam Hospital
Full name of responsible person
Dr Pezhman Alavi nejad
Street address
GI department, Imam Hospital, azadegan street
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jondi Shapur medical univercity
Full name of responsible person
Dr Homeira Rashidi
Street address
research center department of medical univercity
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?